1. Field of the Invention
The present invention relates in general to electrotherapy devices and more particularly to devices and methods for photodynamic and electromagnetic stimulation of living tissue, directly and also indirectly, by stimulation of photosensitive substances introduced into or onto living tissue.
2. Description of Related Science
The mitochondria within the cells of protozoa and metazoa are sources of energy produced by cell respiration. They are moreover capable of synthesizing proteins, because they have a genetic system of DNA and RNA independent of the cell nucleus.
The mitochondrias' main function, however, is vesicular respiration. This is the transformation within the cells of nutrients and oxygen (supplied, amongst other ways, via the bloodstream) into energy and endogenous substances, whereby through this transformation, waste products like water, carbon dioxide, alcohol and lactic acid are produced. Of great importance is adenosine-triphosphoric acid (ATP), which is synthesized by the mitochondria into adenosinediphosphoric acid (ADP) and orthophosphate. Complicated chemical compounds are of great importance as reaction catalysts.
Stimulation of the vesicular respiration, especially a stimulation of the ATP production by cells, is used therapeutically to meet strong demands on cell energy during healing processes, and for weight-reduction, wound-healing and reduction of pain sensitivity due to illness or weakness caused by hypo- or depolarization of the cell membrane. In general, weakening of cells caused by an increase of vesicular respiration due to stress, illness or by old age can be counteracted. In order to achieve stimulation of the mitochondria through optical radiation, two conditions must be fulfilled. The radiation must be of appropriate wavelengths in order to be effective, and a pulse frequency must be chosen to penetrate to an appropriate tissue depth without causing tissue damage or pain.
Moreover, pulsating electromagnetic fields have been shown to exert a positive influence on the bodies of both animals and humans. With the help of pulsating electromagnetic fields it is possible to send protons from electrolytic internal body fluids such as blood or lymph directly and in controlled measures into the surrounding vessel walls and membranes. This is normally not possible, since the lipids in the membranes of the blood vessel walls, which are in contact with the blood, carry a negative charge creating a surface potential which hinders the protons and ions from entering the vessel walls. The pulsating electromagnetic field enables the protons to enter the cell and vessel walls in spite of the barrier. When this occurs, the increased concentration of protons within the cell and vessel walls reverses the polarity of the barrier, thereby hindering the protons and ions from exiting through the cell and vessel walls again. In turn, this phenomenon causes a beneficial change in the local pH value, especially within the vessel walls. Additionally, prolonged exposure to pulsating electromagnetic fields has other effects, such as the electrical constriction of the membranes and vessel walls, the adjustment of polyvalent ion chains, the tangential displacement of absorbed counter ions, the force effect on dielectric bodies in homogeneous and non-homogenous fields, and electro-osmosis.
A device is known (Patent DE-U-8-13852/Normed, E. Larsen). which uses infrared radiation for the photodynamic stimulation of energy in living cells, cells at the surface of the skin and especially cells lying deeper down. The device consists of a supply and control mechanism and an applicator on which infrared radiating (from 900 nm [1 nm=1 nanometer]) semiconductor diodes are mounted with reflectors for the bundling of the IR radiation from the applicator (IR=infrared). In this known device, a generator containing a control-mechanism supplies the semiconductor diodes with current pulses of a frequency within the range of 500-5000 Hz. A disadvantage of the known device is that the semiconductor diodes tend to overheat during use, which causes a decrease in the effectiveness of the device.
The known device therefore does not deliver a constant effect during use. Another disadvantage is that only infrared radiation within a range of 900 nm is available, while other wavelengths may be called for to achieve cell stimulation.
Another device (Patent EPA 0568 666) is used for the photodynamic stimulation of cells. The semiconductor and/or laser diodes radiate light of different wavelengths. With the aid of light sensors the advanced control-system is able to test the patients for the required radiation dose in order to avoid over-stimulation. Furthermore, the radiation outlets in the applicators are covered with a polarization filter, which enhances absorption in the irradiated tissue. The basic equipment consists of a mobile stand, to which machine applicators are connected with a jointed arm. The machine applicators are adapted for the treatment of large tissue-areas, for example the back of humans. The device also includes a control-mechanism, whereby the various parameters for therapy can be adjusted and switched ON and OFF. The device is also connected to a hand applicator designed for the treatment of small tissue-areas, e.g. acupuncture points or dental treatment with the aid of a connectable fibre.
Another device is (EPA Patent 0570 544), which uses electromagnetic fields for therapy on humans and animals. The pulse-shaped electromagnetic fields cause protons to migrate out of the electrolytic internal body fluids into the surrounding vessel walls and membranes. The device produces the electromagnetic pulse-bundles in a certain pulse-rhythm, in which each pulse-bundle is followed by a pause. The basic device consists of a generator for producing the electro-magnetic pulses, connected with a transmitter coil, whose windings are placed on the surface of the base plate. The base plates are manufactured from light, flexible insulating material and mounted in a flat applicator housing placed on a jointed arm connected to the basic device.
In the fields of dermatology and rehabilitation, light is used as a stand-alone therapy for wounds, leg ulcers, eczema, burns, pain, rheumatic disorders etc., and as such is used to stimulate tissue directly. Techniques are known for introducing agents for altering the light absorbing qualities of tissue to enhance the effect of light (for example, U.S. Pat. No. 5,226,907 to Tankovich teaches contamination of hair follicles with a dark particulate material to enhance light-induced heating in the follicles for hair removal).
Treatments have included the application of substances such as photoflim, 5-aminolevulan acid, hematoporphyrin, verteporfin, chlorins, phthalodyanines, phenothiazine, and benzoporphyrin-derivative monoacid-A (ATMPn) onto or into tissue for healing solar keratoses, basal cell carcinoma, melanomas, etc. Such substances are known as “biopharmaceuticals” and treatment with these substances has been called biopharmaceutical therapy. Therapy involving the application of biopharmaceuticals and their subsequent activation by light after they have been absorbed into tissue has been called photodynamic therapy (PDT).
PDT has been used successfully in the treatment of internal inoperable cancers. A biopharmaceutical (specifically, hematoporphyrin) is injected into the tumor tissue, and an optical method known as photodynamic diagnosis (PD) is used to determine when the biopharmaceutical has been absorbed by the entire tumor. Then the tumor tissue is irradiated with light typical for a dye laser, which activates the photosensitive reactors in the hematoporphyrin, whereby singlet oxygen is liberated. Singlet oxygen is toxic to protein and phosphorlipids in the tumor tissue, whereby the tumor is destroyed without destroying the surrounding tissue.
For treatment of skin keratosis (pre-cancerous tissue), trials with, for example, 5-aminolevulinic acid have shown that it can be used effectively in PDT if introduced into oil in a water suspension which is then applied to skin keratosis and then irradiated with a light source. A fast and cosmetically perfect healing has been attained with a very low rate of recurrence compared to conventional treatments, such as cryo-therapy. In view of these favourable test results, it is anticipated that pharmaceutical companies will be marketing the next generations of PDT chemicals in convenient forms, such as creams, suspensions, sprays, etc.
The light source typically used to irradiate PDT chemicals is commonly known as the surgical laser, a solid-state laser which is bulky, and which is expensive both to purchase and to operate. Surgical lasers are designed primarily for cutting, i.e., they output very high energy in a very small spot, and are thus difficult to adapt to the requirements of irradiating a more generalized area for PDT. Further, they generally radiate at a single wavelength Radiation at several wavelengths is desirable in PDT, for several reasons: a single wavelength may cause the patient to experience burning pain in adjacent tissue during treatment; some photosensitive chemicals respond to two different wavelengths; and, some pigmented melanomas do not respond to visible radiation due to absorption in the pigment (typically melanin), and must be irradiated with near-infrared light.
Common dermatological diseases like acne, warts, and onychomycosis (nail fungus) can successfully be treated with light as a stand-alone treatment, but recent work indicates that treatments using PDT (with ALA/5-aminolevulanic acid) give excellent results with only two or three treatments.
In a recent pilot study using PDT to treat acne, the cosmetic results were excellent, and oil gland activity which causes acne, and the resultant inflammation, were reduced for as much as twenty weeks after a series of PDT treatments. (The PDT treatments precipitated immediate but short-term inflammatory reactions.) In general the photodynamic stimulation used in physiotherapy is producing very good results, but in the area of long-term chronic diseases such as gout, arthritis, etc. there is often a need for many treatments, as many as 12-20 treatments spaced over a period of time. Also, initial phases of such treatment often cause reactions, which in turn cause pain and discomfort. A recent trial study showed that using a light and/or laser radiation combined with an electromagnetic field emission resulted in better results, without reactions to the intensive therapy. It seems that the combined radiation has a better penetration due to the electromagnetic fields removing the blocking potential and the vasodilatation of the capillaries, whereby the increased ATP energy is better utilized.
A recent trial in post-surgery light and/or laser therapy after coronary angioplasty and stenting, where the restenosis rate is normally quite high, showed promising results, and here again it is expected that the results can be improved using a light sensitive biopharmaceutical for regeneration and stabilisation of the vessel walls.
Studies also support the theory that a light and/or laser radiation of blood can provide an effective therapy for chronic diseases such as leukemia and cancer, our tests on athletes also support the theory that this therapy improves the immune system and the vitality.
A number of erothrocytes are often damaged in artificial heart-lung machines, but blood irradiated with light and/or laser showed less deformability and the ATP levels were significantly higher. Here too we expect an increased activity of the leukocytes and and lymfocytes by using light sensitive biopharmaceuticals.
For many years large-surface therapy systems for dermatological diseases like psoriasis have been equipped with UV radiation sources, for example UV tubes. Prior to the treatment the patients have received various types of photo-chemical substances like 8-MOP (Oxsoralen), 5-MOP or Meladinine (bathing therapy). Due to the risk of skin cancer and other side effects the use of PUVA therapy has declined during recent years. When more studies have been completed it is expected that PDT will in future be the procedure of choice for treating most chronic dermatological diseases, due to its effectiveness and lack of side effects.
Also due to the risk of skin cancer, tanning on sun-beds has declined much during recent years. Among other side effects is the erythema that follows the first treatments, and most patients, especially those with fair skin, find that their skin becomes very dry and irritated.
Our tests have showed that by using a combination of UV light and photodynamic light produced by semiconductor diodes, we can avoid all the side effects of using sun-beds. It is also expected that the increased vitality (high ATP level) of the skin can counteract the risk of skin cancer.
In classical acupuncture a technique called moxibustion is commonly used for the treatment of deep-lying acupuncture points, especially in chronic diseases. Needles with a special metal handle are used and, after the needles are inserted in the patient, a herbal substance is placed on the handle and combusted, whereby the needle is heated and leads the heat deep into the tissues. The effect is excellent, but western doctors do not like this praxis because of the strong smell, which may linger for several days.
This method can now be replaced by the application of topical light-sensitive lotions over the acupuncture points, which are subsequently radiated with a suitable light and/or laser radiation. Looking at the current state of technology, devices are available for the photodynamic stimulation of human cell energy in the form of red and infrared radiation emitted by laser diodes and semiconductor diodes. These devices are not suitable for intensive, invasive and whole body treatments mainly due to the lack of applicators with suitable adjustable radiation sources for fill surface treatment with combined diagnostic abilities during treatment. The same can be said for existing devices for treatment with pulsating electromagnetic fields. Moreover, a combined treatment with both red/infrared and blue light together with electromagnetic fields is not possible with these devices for the stimulation of light sensitive substances.
A device able to deliver an intensive light radiation with selective multiple wavelengths within the wavelength area of 300-2000 nm and electromagnetic fields is not at present available. Thus the invention is aimed at creating a device for intensive photodynamic therapy, which is capable of stimulating photodynamic energy of selective multiple light and/or laser radiation within a wavelength range of 300-2000 nanometers, capable of treatment with pulsating electromagnetic fields, and can also be used for stimulating light sensitive biopharmaceuticals.